FDA puts back review for Tarceva as first-line NSCLC drug

Roche's Genentech unit and OSI Pharmaceuticals have been told by regulators in the USA that they need more time to look at Tarceva as a first-line treatment for lung cancer.

The US Food and Drug Administration has extended the review period for the supplemental New Drug Application for Tarceva (erlotinib) as a first-line maintenance therapy in advanced non-small cell lung cancer by an additional 90 days. The original Prescription Drug User Fee Act date was today (January 18) but OSI has submitted further data in support of the application and action on the sNDA is now expected by April 18.

The new data comes from the 889-patient Phase III SATURN study in people who received Tarceva immediately after their initial chemotherapy. Investigators believe the data showed that the drug delayed the progression of disease and “importantly helped patients in the study live longer”.

The companies will be hoping this new data goes down better than previous submissions because last month an FDA advisory panel voted 12 to one against recommending Tarceva for the first-line maintenance indication. Panel chairman Wyndham Wilson, head of lymphoma therapeutics research at the National Cancer Institute, said that “at the end of the day, what matters is overall survival” but “the overall survival benefit in this trial is relatively small.”

Tarceva is curerently indicated for people with NSCLC whose disease has progressed after one or more courses of chemotherapy. It is also approved in combination with Eli Lilly’s Gemzar (gemcitabine) chemotherapy for the first-line treatment of advanced pancreatic cancer.